Bölükbaşı Pharma Quality Management process is a quality management system that creates a corporate culture based on the principle of customer and employee satisfaction. As Bölükbaşı Pharmaceuticals, all departments within the Quality Management System and employees at all levels are responsible for implementing the Quality Assurance System documents completely and accurately. Quality Management is not an individual activity. Bölükbaşı Pharma adopts all the principles of quality management and implements its requirements in all technical and administrative units throughout our facility, and is determined and determined to reach advanced targets by raising the quality level in the total of its activities with the quality culture it has created.

This Quality Assurance System, which was prepared to cover all fields of activity of our company, in order for our company to reach the quality it aims in the total of its activities, the general purpose, target and strategies for each unit were emphasized, the task of preparing the application documents and determining the details by giving the principles of method, business processes and success indicators was left to the responsibility of the units. . Following the acceptance of this document by the authorized departments of our company, all technical and administrative departments determine and evaluate the methods, business processes and success indicators to be applied in order to reach the quality targets.

As Bölükbaşı Pharma, it is to help present the activities related to the Quality Management System used in an easy and understandable way.

Our Quality System,

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• GMP [Good Manufacturing Practices]

• GLP [Good Laboratory Practices]

• ISO 13485 [Medical Device Quality Management System]

• ISO 9001:2008 [Quality Management System]

and other legal regulations.

A Quality Management Representative has been appointed in our company to fulfill the requirements of the quality management system. Our Quality Management system was planned, established and put into practice with the team established under the leadership of the quality management representative. At the management review meetings and whenever deemed necessary, the general manager and the relevant unit responsibles attend the meetings, where the factors affecting the quality management system are discussed, the decisions taken are recorded in the meeting minutes form, the revisions required for the quality management system are planned and made when deemed necessary according to the changing conditions. However, maintaining the integrity of the system is provided by the management.

Our Quality Management System has been established, documented and implemented in accordance with the requirements of the ISO 9001:2008 standard, and efforts for continuous improvement of its effectiveness are continued.

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In our establishment,

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The processes needed for our Quality Management System have been defined and implemented within our organization,

The stages of these processes, their effects on each other and their relations with each other were determined.

Necessary methods and criteria have been determined for the efficient operation and control of processes,

Necessary information and resources are provided for these processes,

These processes are monitored, measured and analyzed.

Continuous improvement of processes is ensured in order for our Quality Management System to achieve the planned results.

The continuity and effectiveness of the established Quality Management System are kept under control by means of periodic Internal Audits, Management Review Meetings and Process Performance Measurements, and corrective and preventive actions are initiated when necessary.

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